Regulatory Affairs Specialist

Role & responsibilities

• Prepares the submissions (ANDAs, amendments, supplements including labeling, annual reports) to support commercial business and to be-in compliance to FDA regulations.

• Review CMC submission documents from regulatory perspective to meet scientific and technical requirements for acceptability and approvability by FDA. Escalate the review findings for a timely resolution.

• Leads labeling development for product launches and ensures that all labeling meets company and US regulating health authority specifications.

• Initiate/Review change control process and coordinate with other departments to ensure timely implementation.

• Prepare, review and submit eCTD submissions.

• Collaborates with Regulatory Affairs on submission and implementation strategy for labeling. Create and revise labeling. Proofread and verify all labeling to ensure accuracy and conformity with US FDA regulations. Prepare final printed labeling for FDA submissions (e.g. PDF, SPL, PLR format). Perform Drug listing.

Preferred candidate profile

• Strong understanding of FDA, ICH, CMC and labeling requirements through all phases of development and life-cycle of the product.

• Proven proficiency with relevant FDA/ICH regulations & guidelines for labeling development, implementation, and compliance requirements, and applies understanding to business situations.

• Proven effectiveness with stakeholders in the labeling system from content development through commercial supply.

• Actively supports the systems, processes, and operations for development of and changes to labeling, and assures compliance to those procedures.